Postoperative prostate cancer patients
Conditions
Interventions
De-escalation dose group:De-escalation dose hypofractionated radiation therapy
Standard dose group:Standard dose hypofractionated radiation therapy
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old with a signed informed consent form; 2. Willingness to complete all intervention and steps in the study; 3. Prostate cancer confirmed by radical prostatectomy histology; 4. At least one of the following conditions: 1) >= pT3 or positive margin, 2) postoperative PSA does not decrease to undetectable or increases twice in succession, or PSA >= 0.1ng/ml; 5. Postoperative ISUP Grade Group 1-4 (Gleason score 6-8); 6. pN stage: pN0 or cN0; 7. M0: For patients with clinical suspicion or PSA>0.2 ng/mL, bone scans, MRI, or PET-CT show no metastases; 8. PSA<2.0 ng/mL; 9. ECOG score: 0-2.
Exclusion criteria
Exclusion criteria: 1. More than 6 months ADT before radical prostatectomy; 2. Previous cancer except skin cancer rather than malignant melanoma or any cancer curatively treated > 5 years prior to study entry; 3. Treatment with chemotherapy within 6 months; 4. History of pelvic radiotherapy; 5. Clinically uncontrolled diseases, such as septic shock, unstable angina, New York Heart Association (NYHA) class III or IV heart disease, or clinically unstable arrhythmia;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Biochemical Progression-Free Survival?, bPFS;Adverse events;International Consultation on Incontinence Questionnaire - Short Form, ICI-Q-SF;Abbreviated Version of the Expanded Prostate Cancer Index Composite Instrument, EPIC-26;Overall survival;local progression-free survival, LPFS;Prostate Cancer-Specific Survival;The proportion of patients with PSA50; | — |
Countries
China
Contacts
Public ContactLi Hongzhen
Peking University First Hospital
Outcome results
None listed